A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit on May 1, 2026, ordered the Food and Drug Administration to reimpose a nationwide in-person dispensing requirement for mifepristone, immediately disrupting telehealth prescribing and mail-order access to the drug across all 50 states [1]. The court granted Louisiana's request to roll back regulatory changes the Biden administration finalized in 2023 while the underlying appeal proceeds on the merits [1]. The Supreme Court stayed the ruling three days later, on May 4, temporarily restoring mail-order access pending further review [2].
The Biden-era changes had modified mifepristone's Risk Evaluation and Mitigation Strategy, known as a REMS, to allow certified pharmacies and telehealth providers to dispense the drug without an in-person visit [1]. Louisiana, represented by Attorney General Liz Murrill, challenged those modifications, arguing the FDA exceeded its statutory authority under the Food, Drug, and Cosmetic Act when it relaxed the dispensing conditions [1]. Mifepristone manufacturers Danco Laboratories and GenBioPro, both parties to the litigation, opposed the state's challenge and supported the 2023 REMS changes [1].
The Fifth Circuit's order, before it was stayed, had immediate practical effect: pharmacies and telehealth providers faced uncertainty about whether continued mail dispensing exposed them to regulatory liability [1][2]. The Supreme Court's May 4 intervention, granted in a brief administrative stay, returned the pre-ruling status quo while the justices considered Louisiana's application for more extended relief [2]. Justice Samuel Alito was identified in connection with the emergency application, consistent with his role as the Circuit Justice for the Fifth Circuit [1].
The case now returns to the Supreme Court in a posture that echoes the court's 2023 engagement with mifepristone access in FDA v. Alliance for Hippocratic Medicine, where the justices unanimously reversed an earlier Fifth Circuit decision restricting the drug on standing grounds [1]. That prior ruling left the merits of FDA's REMS authority unresolved, and Louisiana v. FDA presents the court with a direct vehicle to address them [1]. Briefing schedules and oral argument dates had not been publicly set as of early May 2026, but the combination of a circuit court order with nationwide effect and an emergency stay signals the court is likely to take up the case on an expedited basis [1][2].
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